Label: VAPOR INHALER- levmetamfetamine nasal decongestant inhalant

  • NDC Code(s): 0363-0564-50, 0363-0564-53
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • Active ingredient (per inhaler)

    Levmetamfetamine 50 mg

  • Purpose

    Nasal decongestant

  • Use

    for temporary relief of nasal congestion due to:

    • the common cold
    • hay fever or upper respiratory allergies
  • Warnings

    When using this product

    • do not exceed recommended dosage
    • temporary burning, stinging, sneezing, or increased nasal discharge may occur
    • use of this container by more than one person may spread infection

    • do not use for more than 7 days
    • use only as directed
    • frequent or prolonged use may cause nasal congestion to recur or worsen

    Stop use and ask a doctor if symptoms persist

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine
    • do not use more often than every 2 hours
    adults and children 12 years of age and over 2 inhalations in each nostril
    children 6 to under 12 years of age
    (with adult supervision)     		1 inhalation in each nostril
    children under 6 years of age ask a doctor
    children under 2 years of age do not use
  • Other information

    • this inhaler is effective for a minimum of 3 months after first use
    • keep inhaler tightly closed
    • store at 59°-86° F (15°-30° C)
  • Inactive ingredients

    bornyl acetate, camphor, lavender oil, menthol, methyl salicylate

  • Questions or comments?

    1-800-walgreens (1-800-925-4733)

  • Principal Display Panel – 3 Inhaler Carton

    VALUE SIZE

    NDC 0363-0564-53

    Contains 3 of NDC 0363-0564-50

    Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    Vapor Inhaler

    LEVMETAMFETAMINE / NASAL DECONGESTANT

    Nasal Decongestant

    NET WT 0.007 OZ (198 mg) PER INHALER

    TOTAL NET WT 0.021 0Z (594 mg)

    3
    INHALERS

    Principal Display Panel – 3 Inhaler Carton
  • INGREDIENTS AND APPEARANCE
    VAPOR INHALER  
    levmetamfetamine nasal decongestant inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0564
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVMETAMFETAMINE (UNII: Y24T9BT2Q2) (LEVMETAMFETAMINE - UNII:Y24T9BT2Q2) LEVMETAMFETAMINE 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    BORNYL ACETATE (UNII: 213431586X)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0564-501 in 1 BLISTER PACK07/01/2016
    1198 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0363-0564-533 in 1 BLISTER PACK07/01/2016
    2198 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2016
    Labeler - Walgreens (008965063)
    Registrant - Aphena Pharma Solutions-Maryland, LLC (829739833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions-Maryland, LLC829739833manufacture(0363-0564) , pack(0363-0564) , label(0363-0564)
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